NCT04825327: PreFIT

Predicting the Future: Incipient Tuberculosis

Completed Last updated 5 February 2025

What this trial tests

trial in Tuberculosis in 3,016 participants. Completed in 31 January 2025.

Timeline

21 April 2021

Primary endpoint
31 January 2025

31 January 2025

Quick facts

Lead sponsor	Amsterdam Institute for Global Health and Development
Status	Completed
Study type	OBSERVATIONAL
Enrollment	3,016
Start date	21 April 2021
Primary completion	31 January 2025
Estimated completion	31 January 2025
Sites	3 locations across South Africa, Mozambique, Uganda

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →

Sponsor

Amsterdam Institute for Global Health and Development

Who can join

Adults 12 to 60, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators will study, prospectively, if contacts (household or close contacts) of tuberculosis (TB) patients with high C-reactive protein (CRP), low hemoglobin (Hb) levels, and a positive Xpert Host Response (HR) cartridge result develop active TB within 12 months. They will also investigate if there is a correlation between progressing to active TB within 12 months and having high levels of the iron homeostasis markers (Hepcidin, Ferritin and Transferrin).

Identified index cases who agree to participate will refer their household or close contacts to also join the study. These contacts will be tested for TB and only contacts who are negative will be enrolled and followed-up at 6 months and 12 months. Blood samples will be collected at baseline and 6 months for testing. During the study period, TB testing will be done on contacts who meet symptoms criteria. At 12 months, all contacts will undergo a chest x-ray to assist in the diagnosis of TB.

PreFIT will target people aged 12 to 60 years of age and both HIV negative and positive. 1515 trial participants will be recruited at Stellenbosch University in South Africa, 1515 at Fundaçao Manhiça in Mozambique and 1010 at Makerere University in Uganda, respectively.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Accuracy and clinical utility of near-point-of-care blood tests for predicting incident tuberculosis in exposed contacts in high burden settings: a multi-country observational cohort study
   Abdulgader S, Chiwaya A, Banuls M, Ssengooba W, et al · · 2026 · DOI 10.21203/rs.3.rs-9126754/v1
2. Bioequivalence of C-reactive protein in fingerprick blood and serum measured using the point-of-care LumiraDx test for tuberculosis diagnosis in exposed contacts
   Chiwaya AM, Abdulgader SM, Manjate P, Sserubiri J, et al · · 2025 · DOI 10.21203/rs.3.rs-8161424/v1